News Column

Patent Issued for Device, Kit, and a Method for Handling a Medical Implant

May 14, 2014



By a News Reporter-Staff News Editor at Journal of Engineering -- A patent by the inventor Ammann, Oliver (Burgdorf, CH), filed on October 25, 2006, was published online on April 29, 2014, according to news reporting originating from Alexandria, Virginia, by VerticalNews correspondents.

Patent number 8709014 is assigned to Stryker Trauma GmbH (DE).

The following quote was obtained by the news editors from the background information supplied by the inventors: "The invention relates to a medical device for handling an implant and a method of handling an implant.

"The invention further relates to a medical kit for handling an implant.

"Bone plates may be fixed at a bone using nails or screws in order to stabilize a fracture.

"US Publication 2006/0116686 discloses a screw fastener for attachment to an orthopedic component such as an orthopedic plate for use in connection with fracture fixation, joint reconstruction or spinal stabilization or fusion as having a shank with at least two different shank diameters, one in a plate engaging portion of the shank and one in the bone or other component engaging portion of the shank. At least two of the different shank diameters on the shank include threads, the threads on the two different diameter portions each having substantially the same thread height and pitch. A plate having a threaded aperture, or an adapter having a threaded aperture, is sized such that the threads of the smaller diameter shank portion engage and cooperate with the internal threads of the aperture to correctly align the screw fastener and the implant as the screw fastener is threaded through the implant. The threads on the larger diameter shank portion and the internal threads of the aperture of the implant are sized so that the threads of the larger diameter shank portion are fully engaged with the internal threads of the orthopedic implant.

"U.S. Publication 2004/0254579 discloses an implantable orthopedic device having a load-bearing element, such as a bone plate, with at least one opening for a fixation element and one insert which can be inserted in an inclined opening in a receptacle in the bore. This insert has an external form that is at least partially complementary to the internal form of the receptacle and a central through-bore for receiving the body of the fixation element such as a bone screw. The insert also provides a locking system for holding the insert in the receptacle, in which the insert exhibits at least one locking mechanism with which conformal locking with the load-bearing element may be achieved.

"U.S. Publication 2006/0116680 discloses an extractor device to extract an insert to be used with a bone connection element such as a bone plate having at least one opening for a bone screw used with said insert. The extractor device has an outer hollow sleeve having proximal abutment surface being able to engage a surface portion of the bone connection element, and an inner bar having a diameter enabling the insertion of the bar into the hollow sleeve. The bar has a threaded leading end to engage the thread of the insert to be extracted. The hollow sleeve has an inner thread and the inner bar has an outer threaded element for engaging the inner thread of the hollow sleeve. The outer threaded element is positioned with respect to the bar in a longitudinal position to enable the thread at its leading end to extend beyond the proximal abutment surface of the sleeve to be threaded into the insert.

"However, there is still a need for an efficient handling of an implant."

In addition to the background information obtained for this patent, VerticalNews journalists also obtained the inventor's summary information for this patent: "According to exemplary embodiments of the invention, there are provided a medical device for handling an implant, a medical kit for handling an implant, and a method of handling an implant.

"According to an exemplary embodiment of the invention, a medical device for handling an implant is provided, the medical device comprising a loading section adapted to be loaded with an insert element to be inserted into a hole formed in an implant, and a guiding section adapted to be guided by a pin inserted into the hole formed in the implant for guidedly inserting the insert element into the hole formed in the implant.

"According to another exemplary embodiment of the invention, a medical kit for handling an implant is provided, the medical kit comprising a medical device having the above mentioned features.

"According to still another exemplary embodiment of the invention, a method of handling an implant is provided, the method comprising loading a loading section of a medical device with an insert element to be inserted into a hole formed in an implant, and guiding a guiding section of the medical device by a pin inserted into the hole formed in the implant for guidedly inserting the insert element into the hole formed in the implant.

"In the context of this application, the term 'medical device' may particularly denote any apparatus being suitable (for instance with regard to biocompatibility, sterilization, etc.) for applications related to the health system, like surgery. Particularly such 'medical devices' may be appropriate for use by physicians, nurses, etc.

"The term 'handling' may particularly denote any manual operation of the medical device by a user, for instance before, during or after surgery.

"The term 'implant' may particularly denote any physical structure which is foreseen or designed to be introduced into or attached to a body of a physiological object, like a human being or an animal. Examples for implants are bone plates adapted to be connected to a bone, or bone screws adapted to be screwed into a bone.

"The term 'insert element' may particularly denote any component being shaped and dimensioned to be securely inserted in a target structure. More particularly, an insert element may be an adapter piece to be inserted into a hole of a bone plate to thereby equip an unthreaded hole with a thread foreseen in the insert element. Thus, inserting an insert element into the target structure may selectively adjust the functional properties of the target structure by help of the insert element.

"The term 'loading' may particularly denote detachably equipping a loading section of the medical device with an insert element for a selective deposition of the insert element at a target apparatus.

"The term 'guidedly inserting' may particularly denote inserting the insert element into a hole of the implant under control of a mechanical guiding mechanism to thereby allow accurate spatial positioning (in longitudinal and/or in angular manner) of the insert element into the hole of the implant.

"The term 'forceps' may particularly denote a mechanism having two leg elements (or branches) which are mounted (for instance angularly to one another) for an anatomically suitable actuation by a hand of an operator. When actuating a forceps mechanism, the spatial relationship of the leg elements (or branches) may be selectively altered, thereby mechanically acting precisely on a portion to be handled by the forceps, particularly making use of a lever action.

"The term 'kit' may particularly denote a set comprising multiple components adapted for cooperative use. For instance, such a kit may be a modular construction set including individual or separate components for functional interaction. The term 'kit' may particularly denote an arrangement of a plurality of individual or separate components which may be used independently from one another but which form together a medical system.

"The medical kit may comprise the insert element, for instance an insert element having one or a plurality of the above-mentioned properties.

"According to an exemplary embodiment, a medical device is provided which allows to assist an operator in inserting an insert element/locking insert into a hole of an implant, for instance of a bone plate, by simply guiding the medical device along a guiding pin which has been previously inserted into the hole. When a tip of the medical device loaded with the insert element has reached the hole of the bone plate, the medical device may snap on the pin. Applying a pressure on the medical device may then promote insertion of the insert element into the hole. Actuating a button of the medical device may then release the medical device from the pin and may allow a removal of the medical device from the implant with the fixed insert element, and subsequent a removal of the pin.

"A mechanism may thus be provided allowing to click or snap an outer surface of the insert element into a corresponding recess of the bone plate. Such an insert element may comprise an inner thread so as to allow a user to convert an unthreaded hole in a bone plate into a threaded hole using the insert element as an adapter. By taking these measures, such an inner thread may be formed indirectly in the bone plate making use of the insert element, for instance for screwing a bone screw into the threaded insert element inserted in the bone plate and into the bone.

"According to an exemplary embodiment, an angularly stable plate or implant having oblong holes and threaded holes may be selectively manipulated so as to be brought in accordance with a configuration which is desired for a specific application, for instance a surgical operation for treating a fracture of a bone. With such a method of inserting the insert element into an oblong hole with only a small pressure acting on the implant and on the bone, this oblong hole may be functionally converted or adjusted to provide a threaded hole. Such a mechanism may be realized using a forceps for pressing the insert element into the oblong hole, wherein the forceps may be guided by a guiding pin.

"According to an exemplary embodiment, a locking inserter may be provided which may be used before or during a medical operation, since an essentially forceless insertion of the locking insert is enabled also during an operation, that is in a state in which the implant is already mounted on or in a body of an object under examination (like a human or animal patient). Therefore, according to an exemplary embodiment, a minimal invasive method may be provided to insert such an (for instance threaded) insert element into an implant which may already be located at or in a body.

"According to an exemplary embodiment, a bone plate or any other implant may be attached to a bone (for instance a broken bone). Then, a pin sleeve may be attached to a hole formed in the bone plate. Through such a pin sleeve, a pin may be guided through the hole of the implant which pin can be screwed into the bone using an appropriate power tool. Such a pin may have a self-tapping and self drilling thread, so as to be able to be threaded inside the bone with low effort. When the pin is fixed in the bone as a mechanical guiding structure, the pin sleeve may be removed from the arrangement, in which the pin has already been screwed into the bone.

"For continuing the spatially controlled insert element insertion procedure, the locking insert may be loaded or mounted on the forceps. The forceps may then be shifted over the pin so that the pin is received in an inner bore of the forceps, thereby allowing the inner bore and the pin to be cooperatively guided. The locking insert provided on a tip of the forceps may have a hole through which the pin may be guided when the pin is guided through the forceps. In other words, the pin and the forceps may be guided with respect to one another by guiding the pin through the guiding section of the forceps. It is also possible that the pin inserted in such a guide section of the forceps is fastened in the forceps at a particular position, to enable stability with regard to a longitudinal position and with regard to an angular position. When the forceps has been guided towards the oblong hole of the implant, the forceps may be fixed to the pin by snapping. Then, pressing on an actuation section of the forceps may allow the loaded insert element (optionally supported by a force, like a spring force) to be pressed into the implant, for instance into an oblong hole of a bone plate. The forceps may then be disassembled from the arrangement, that is to say may be removed from the bone plate. For this purpose, a button or any other actuation mechanism may be actuated so as to release the forceps from the pin to allow the removal of the forceps. Then, the pin may be screwed out of the bone. What remains is the bone plate having the insert element pressed therein, and a hole preformed in the bone by the pin. Then, a bone screw may be screwed in the bone making use of the thread of the insert element and of the pre-formed hole in the bone. Such a bone screw may then be forced to extend into the bone, particularly into the hole which has previously been formed by the pin. Therefore, a separate bore procedure may be avoided. In order to use the hole defined by the pin, the outer diameter of the pin may be adjusted to a core or root diameter of the bone screw.

"Therefore, according to an exemplary embodiment, a locking insert forceps may be provided. To obtain axially stable fixation in the diaphyseal region of long bones with a locking plate system, a locking insert may be used. With a locking insert mechanism according to an exemplary embodiment of the invention, it may be made possible to insert the locking insert intra operatively. Conventionally, it may be necessary to press the locking insert into the implant on the back table before implanting the plate. Because it may be desired by a surgeon to insert the locking insert intraoperatively and minimally invasive, the locking insert forceps according to an exemplary embodiment of the invention may be used.

"Therefore, a device is provided that allows a minimal invasive insertion of locking inserts intra operatively. It is possible to apply essentially no or only a small force to the fracture during this procedure, thereby preventing a loss of reduction.

"According to an exemplary embodiment, a centering pin with a threaded tip may be screwed through a guide for the centering pin into the bone. The guide for the centering pin may fit into a hole in the plate which may be compatible with the locking insert. With the guide for the centering pin, it may be ensured that the centering pin has the correct angle and position.

"After setting the centering pin, the locking insert forceps holding the insert element may be inserted over the centering pin. The forceps may snap into the grooves of the centering pin. With this connection, the counter force (or counter poise) for pressing the locking insert in the plate may be generated.

"The medical device may comprise a guiding section which may be adapted to guide a pin, inserted into the hole formed in the implant. Such a guiding section may be a hollow tube in an interior of the medical device which may be sized to be able to receive the pin. By taking this measure, a proper geometrical arrangement between medical device and pin may be ensured or adjusted. This may allow to accurately define position and angular property of the system.

"Such solutions may be advantageous over a conventional approach. According to such a conventional approach, to insert the locking inserts into implants, a locking insert inserter is used. In such a conventional approach, a locking insert is screwed on the inserter and is pressed into the implant on the back table. However, exemplary embodiments of the invention may be advantageous compared to such a solution, since the force acting on the (fractured) bone may be significantly reduced or even essentially eliminated.

"Next, further exemplary embodiments of the medical device will be explained. However, these embodiments also apply for the medical kit and for the method.

"The device may comprise an actuating section adapted to be actuated by a user for triggering insertion of the insert element into the hole formed in the implant. Such an optional actuating mechanism may be actuated by a hand of a user operating the device, allowing the release of the loaded insert element from the medical device and connecting it to the implant.

"The loading section may comprise a spring element biased for holding the insert element. For instance, a flat spring or leaf spring or any other resilient mechanism (like a hollow cylindrical rubber element) may be used to detachably hold the insert element.

"The loading section may be adapted to hold the insert element along at least a part (particularly along the entirety) of a circumference or perimeter thereof. For instance, the insert element may have an essentially circular outer circumference, wherein the loading section may surround this circumference partially or entirely.

"The loading section may be adapted to releasably hold the insert element. In other words, the insert element can be loaded onto the loading section in a reversible manner. By actuating an actuation mechanism or by simply pressing on a component of the medical device attached to the hole in the implant, the loaded insert element may be removed from the loading section, for instance may be pressed into a hole of an implant.

"Such an actuating section may comprise a button, a switch, and/or an actuable grip. For example, a surgeon or any other user may press a button for triggering insertion of the insert element into the hole of the implant or may simply pressing the loaded insert element into the hole of the implant. Alternatively, a switch may be operated to enable insertion of the insert element into the hole. Another possibility is the usage of a hand grip as used in forceps or scissors, wherein approaching the legs of the grip may initiate insertion of the insert element into the hole. Such a lever mechanism may allow operating the medical device with low force.

"The guiding section may comprise a fastening mechanism adapted for detachably fastening the guiding section to the pin. Such a fastening mechanism may be a snap-fit connection, an engagement connection, a press-fit connection, a positive locking connection or a force closure connection. Using such a fastening mechanism which may be operated by a user, the pin inserted into the guiding section may be spatially fixed so as to ensure a proper arrangement or alignment between medical device and pin.

"The fastening mechanism may be actuable by an, actuable button, an actuable switch, and/or an actuable grip.

"The medical device may particularly be adapted as a forceps. The term 'forceps' may, particularly denote an arrangement in which two legs of a hand grip may be held by the hand of a user. When one or both legs are operated manually, the function of the medical device may be carried out, for instance insertion the locking insert into a bone plate and/or decoupling of the guiding section from the pin.

"In the following, further exemplary embodiments of the medical kit will be explained. However, these embodiments also apply to the medical device and to the method.

"Apart from the medical device (a forceps, according to an exemplary embodiment), the medical kit may comprise the insert element which may be adjusted to the medical device (for instance with regard to dimensions, shapes, etc.).

"Particularly, the insert element may comprise a structure or a body having a through hole which may be penetrated by the pin and by a bone screw. Such an insert element may comprise an inner thread formed at a, wall delimiting the through hole. Therefore, the insert element may have an essentially nut-shaped configuration and may serve to provide an inner thread for providing a screw connection between the insert element comprising implant and a bone screw.

"The through hole may be adapted to be penetrated by a guiding pin to be inserted into the hole formed in the implant. In a scenario in which the insert element is loaded at the medical device (for instance a forceps) and the guiding pin is inserted through the hole of the bone plate into the bone of the patient, the guiding pin may be guided through the through hole of the insert element and through the guiding section of the medical device. This allows a proper alignment of the individual components of the medical system to be ensured.

"The insert element may comprise a fastening element adapted to be fastened to a correspondingly designed further fastening element formed in the hole of the implant. The fastening element and the further fastening element may be adapted to provide a snap-fit connection, an engagement connection, a press-fit connection, a positive locking connection, or a force closure connection. In other words, the insert element and the implant may be matched to one another so that inserting the insert element into the hole of the implant may automatically generate a stable and fixed connection between insert element and implant.

"The medical kit may comprise the implant having one or a plurality of the above-mentioned properties. Such an implant may be, for instance, a bone plate.

"Such an implant may comprise the hole formed in a plate-like substrate and may comprise one or more further holes formed in the substrate. The hole may be unthreaded, and at least one of the further holes may have an inner thread. Therefore, the implant may be a bone plate with threaded and unthreaded holes, wherein insertion of an insert element into one of the unthreaded holes may convert this unthreaded hole into a threaded hole. This may allow increased flexibility for a user, for instance to generate further threaded holes in a bone plate. At least a part of the unthreaded holes may be oblong, thereby allowing positional adjustment of the insert element within the oblong hole.

"The medical kit may comprise the pin adapted to be inserted through the hole formed in the implant into a bone.

"Such a pin may have a threaded end portion, which may be self-tapping and self-drilling. Therefore, the end portion of the pin which may be shaped as a long rod may be directly screwed (using a conventional power tool) into a bone, without the need to pre-bore the bone. The pin may then have the function to provide a bore in which later a bone screw may be inserted, and to simultaneously provide a mechanical guiding for the forceps or medical device.

"The pin may be adapted to be guidable through the insert element and through the guiding section of the medical device. This may allow the medical device to be mechanically guided by the pin, thereby increasing the accuracy of positioning individual components with respect to one another.

"A pin insertion sleeve may be provided as a separate tool which may be removably attached to the hole formed in the implant and which may comprise a guiding bore through which the pin is guidable to thereby guide the pin through the hole formed in the implant. Such a pin insertion sleeve may be an auxiliary tool which may ensure the proper positioning of the pin within the hole of the implant protruding into the bone.

"The aspects defined above and further aspects of the invention are apparent from the examples of embodiment to be described hereinafter and are explained with reference to these examples of embodiment.

"The invention will be described in more detail hereinafter with reference to examples of embodiment but to which the invention is not limited."

URL and more information on this patent, see: Ammann, Oliver. Device, Kit, and a Method for Handling a Medical Implant. U.S. Patent Number 8709014, filed October 25, 2006, and published online on April 29, 2014. Patent URL: http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=104&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=5197&f=G&l=50&co1=AND&d=PTXT&s1=20140429.PD.&OS=ISD/20140429&RS=ISD/20140429

Keywords for this news article include: Stryker Trauma GmbH.

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Source: Journal of Engineering